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This column is intended to address questions posed by you, our subscribers. These questions are submitted from a diverse audience, including officials of companies that manufacture or distribute FDA-regulated products, regulatory affairs professionals, compliance officers, clinical trial professionals, and marketing and communications officials. The questions are usually very thoughtful, and the responses to the questions may be of interest to other subscribers. Our answers to inquiries, and all our publication and webinar content, are designed to provide accurate and authoritative information. However, they do not constitute legal or other professional advice. Should you require legal advice or other expert assistance, you should seek the services of a competent professional person. Do you have a question for the managing editor? Do you have an experience that you’d like to share about one of the topics discussed? Type your name, the subject of your question, and the question below, and then click on the “Submit” button, or send an email directly to us at fdaeditors@thompson.com.